510(k) Report

510(k) · Cleared

Cleared

Curios

K090641510(k) TraditionalCleared Oct 23, 2009227-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Progentix Orthobiology BV · MQV Filler, Bone Void, Calcium Compound

Cleared on Oct 23, 2009 as substantially equivalent to K994337 (Orthovita Co., 2000) and 1 other predicate after a 227-day review. Its family tree reaches back 3 generations to 1996. 79 later devices descend from it.

Decided
Oct 23, 2009
Review
227 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K960978 (1996). 5 ancestors in all. 79 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1997: 1 other ancestor2019: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2021: 3 descendants cleared2022: 4 descendants cleared2024: 24 descendants cleared2023: 13 descendants cleared2025: 19 descendants cleared2026: 11 descendants clearedK960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 1996K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K030131 · Ossatura BCP Bone Void Filler · Isotis NV · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 31 descendants4 generations forward: 25 descendants5 generations forward: 9 descendants6 generations forward: 2 descendants K030131 · Ossatura BCP Bone Void Filler · Isotis NV · 2003K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19960+5
  1. Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 1 generation backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
  4. This deviceK090641 CuriosProgentix Orthobiology BV · 2009
  5. Descendant · cites it directly · 76 of its ownK151584 AttraX PuttyProgentix Orthobiology BV · 2015
  6. Descendant · cites it directly · 71 of its ownK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
  7. Descendant · 2 generations on · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
  8. Descendant · 3 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
  9. Descendant · cites it directly · 12 of its ownK161859 MagnetOsXpand Biotechnology BV · 2017

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2015: 12017: 32019: 12021: 32022: 42023: 132024: 242025: 192026: 11
2015high 24 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 79 · See all
  • K151584AttraX PuttyProgentix Orthobiology BV · 2015 · cites it directly76descendants
  • K191974NuVasive AttraX PuttyNu Vasive, Incorporated · 2019 · cites it directly71descendants
  • K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · 2 generations on66descendants
  • K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 3 generations on29descendants
  • K161859MagnetOsXpand Biotechnology BV · 2017 · cites it directly12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−2K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−1K030131Ossatura BCP Bone Void FillerIsotis NV2003—
0 (this device)K090641CuriosProgentix Orthobiology BV2009—
+1K151584AttraX PuttyProgentix Orthobiology BV2015—
+1K191974NuVasive AttraX PuttyNu Vasive, Incorporated2019—
+2K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar…Nu Vasive, Incorporated2021—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine2022—
+1K161859MagnetOsXpand Biotechnology BV2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201730
201910
202130
202240
2023130
2024240
2025190
2026110
FIG. 1 — Lineage of K090641, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQV device

  1. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K994337Vitoss Scaffold Synthetic Cancellous Bone Void Filler
Summary page 1
…classified (Product Code MQV) (unclassified) 5.4 PREDICATE DEVICES Proprietary name: VitoSSTM Scaffold (OrthoVita), K994337 Proprietary name: OsSaturaTm BOP (IsoTis), K030131 5.5 DEVICE DESCRIPTION…
Orthovita Co.2000—
*K030131Ossatura BCP Bone Void Filler
Summary page 1
…PREDICATE DEVICES Proprietary name: VitoSSTM Scaffold (OrthoVita), K994337 Proprietary name: OsSaturaTm BOP (IsoTis), K030131 5.5 DEVICE DESCRIPTION CuriOSTM is a micro-structured calcium phosphate resorbable bone void…
Isotis NV2003—

Also cleared against K994337: 25 other devices →

What descends from it? (79)

See all 79

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151584AttraX PuttyProgentix Orthobiology BV201576
K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971
K161859MagnetOsXpand Biotechnology BV201712
K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K151584 (Progentix Orthobiology BV, 2015) has gone furthest, with 76 descendants of its own.
  • 25 other devices also cite its predicate K994337.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender…

Read the full statement (120 words)

CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K090641: Curios.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090641

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026